MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; EMPOWR CR KNEE TIBIAL INSERT, LEFT, SIZE 7, 14MM

Model Number	344-14-707
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported, ""the patient was unstable and had a ni allergy.He was going to just do a poly swap but decided to pull it all because of the allergy.Age: unk.Gender: female"" the previous surgery and the surgery detailed in this event occurred 4 years, 3 months, 14 days apart.Item number: 344-14-707.Item description: empowr cr kneetm tibial insert, left, size 7, 14mm.Lot number: 633v1001.Part revision: a.Product type: knee.Manufacture date: 01-jul-2017.Expiration date: 26-jun-2022.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.Except for an undocumented ni allergy.There were no findings during this evaluation that indicate that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Root cause: the root cause of this complaint was a revision surgery performed due to joint instability and a nickel allergy.The patient's pre[?]existing condition (nickel hypersensitivity) contributed to the need to replace the tibial knee insert.No information was provided regarding the patient's activities or behaviors that may have contributed to the event.Multiple factors outside of djo surgical's control can contribute to such occurrences.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: a review of the device history record(s) shows that the reported component(s) used in the previous surgery met design and manufacturing requirements at the time of release for use.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.
Event or Problem Description
The patient was unstable and had a ni allergy.He was going to just do a poly swap but decided to pull it all because of the allergy.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR CR KNEE TIBIAL INSERT, LEFT, SIZE 7, 14MM
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 24520809
• Report Number: 1644408-2026-00374
• Device Sequence Number: 9759140
• Product Code: JWH
• UDI-Device Identifier: 00190446215547
• UDI-Public: 00190446215547
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K170573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: 344-14-707
• Device Lot Number: 633V1001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130-03-732 155N1944; 243-01-107 276W1082; 353-01-107 192W1021
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female